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Effects of Total Intravenous Anesthesia With Propofol-remifentanil Versus Inhalational Anesthesia With Sevoflurane on Quality of Recovery in Patients Undergoing Transsphenoidal Surgery for Pituitary Tumor

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02813044
Enrollment
82
Registered
2016-06-24
Start date
2016-06-16
Completion date
2018-06-15
Last updated
2020-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary Tumor

Keywords

anesthesia, intravenous, neurosurgery, pituitary neoplasm, postoperative period

Brief summary

A number of studies have compared the effects of total intravenous anesthesia(TIVA) versus inhalational anesthesia on perioperative period during transsphenoidal surgery. However, they have limitations especially for the phase of recovery after anesthesia: a fragmentary assessment. Quality of Recovery 40 (QoR-40) questionnaire was multi-dimensionally designed to assess the degree of recovery, specially after anesthesia and surgery. In this study, the investigators aim to compare the quality of recovery after inhalational anesthesia and after TIVA through QoR-40 questionnaire in patients undergoing transsphenoidal surgery for pituitary tumor under general anesthesia.

Interventions

In the TIVA group,anesthesia is induced and maintained by effect-site target controlled infusion of propofol and remifentanil.

DRUGinhalation anesthesia group

In the inhalation anesthesia group, anesthesia is induced by pentothal sodium 4-6mg/kg and remifentanil 1 μg/kg, and then maintained with end-tidal sevoflurane concentration of 0.8 to 1 MAC and continuous infusion of remifentanil at 0.1-0.3μg/kg/min.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients over age 19 * Scheduled to undergo transsphenoidal surgery for pituitary tumor * ASA class I and II

Exclusion criteria

* Left ventricular ejection fraction \< 55% * Third-degree atrioventricular block * Second-degree atrioventricular block (P:QRS ratio of 3:1 or higher) * Fever * History of myocardial infarction, stroke or cardiac surgery within the previous 1 year * Severe neurological disease * Use of sedative, opioid or sleep-inducing drugs * Allergic history of any study drug * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
QoR-40 score1 dayWe compare the QoR-40 scores of two groups 1 day after the operation.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026